Pregnancy RelatedNCT05250479
Effect of Mindfulness Education in Primiparous Pregnant Women
A study testing Mindfulness education in people with Pregnancy Related and Mindfulness, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
While adaptation is generally achieved to the psychological changes that develop during pregnancy, some women may experience psychological changes such as contradiction, uncertainty, introversion, passive personality, addiction, fear, and anxiety in different periods of pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Mindfulness, Fear of Childbirth
- What is being tested?
- Mindfulness education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2021to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- over 18 years
- 28-32. in gestational week
- First pregnancy
- Understands and speaks Turkish
- Single pregnancy
- Having at least primary school education
Who cannot join
- Having a high-risk pregnancy
- Receiving psychotherapy or medication in the last six months before the study
- with chronic disease Participating in childbirth preparation courses Planning a cesarean delivery with a diagnosed psychiatric illness Pregnant women with previous yoga and meditation experience Pregnant women with a high gestational age will be excluded from the study due to the possibility of giving birth before the end of the follow-up period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdogan University Training and Research Hospital
Rize
Ordu University
Nülüfer ERBİL, Prof. Dr.
About this study
Official title: Effect of Mindfulness Education on Fear of Childbirth, Mode of Delivery, Childbirth Experience and Prenatal and Maternal Attachment in Primiparous Pregnant Women
While adaptation is generally achieved to the psychological changes that develop during pregnancy, some women may experience psychological changes such as contradiction, uncertainty, introversion, passive personality, addiction, fear, and anxiety in different periods of pregnancy. During this period, the fear of childbirth may also be experienced in pregnant women. Fear of childbirth or tokophobia is a phobic condition in which a woman avoids giving birth despite desperately wanting a baby. While fear of childbirth can have a negative impact on women's psychological health during pregnancy and birth experience, it is associated with negative obstetric outcomes and postpartum mental health problems. It is possible that the fear of childbirth reduces the mother's attachment to the fetus. Fear increases avoidant attachment and anxiety, which may be associated with lower commitment scores. There is a strong relationship between fear of childbirth and negative birth outcomes. Both affect the psychological well-being of the mother, adjustment to motherhood, and the quality of the mother's relationship with the baby. Knowing the fear of childbirth is important as it is associated with various health problems such as certain physiological and obstetric disorders and they can increase the possibility of emergency cesarean section. Mindfulness-based interventions combine elements of established cognitive behavioral therapy and psychoeducational content to support a self-effective approach to reduce stress-related symptoms and improve mental and physical well-being. Mindfulness-based practices that involve focusing on the present moment and accepting life without judgment are one of the effective ways to prepare for childbirth, help women feel more empowered and aware of their motherhood processes, and give mothers the opportunity to share knowledge and emotions. Mindfulness-based birth education intervention appears to be applicable for women and is associated with improvements in women's sense of control and confidence in giving birth.
- Conditions
- Pregnancy Related, Mindfulness, Fear of Childbirth, Attitude
- Being tested
- Mindfulness education
- Keywords
- primiparous, pregnant women, fear of childbirth, prenatal attachment, mindfulness education, childbirth experiences, mode of birth, maternal attachment, nursing
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness educationBehavioural
44 primiparous pregnant women will receive mindfulness education
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 44 pregnant women won't receive mindfulness training |
| experimental group "mindfulness education" | Experimental | mindfulness education 44 pregnant women will receive mindfulness training Receives: Behavioral: Mindfulness education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)
determining the level fear of childbirth
Measured: 28-32. pregnant women
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)
determining the level fear of childbirth
Measured: After 32 weeks of pregnancy
Prenatal Attachment Inventory
determine prenatal mother-infant attachment
Measured: 28-32. pregnant women
Prenatal Attachment Inventory
determine prenatal mother-infant attachment
Measured: After 32 weeks of pregnancy
Secondary outcomes (2)
Maternal Fetal Attachment Scale
determine maternal fetal attachment
Measured: postpartum 1st month
Wijma Delivery Expectancy/Experience Questionnaire B (W-DEQ B)
determining the level fear of childbirth
Measured: postpartum 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start20 Dec 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem AKIN, Ordu University
- Investigators
- Nülüfer Erbil, PhD, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250479
- Sponsor's protocol ID
- ozlem20
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness Education on Fear of Childbirth, Mode of Delivery, Childbirth Experience and Prenatal and Maternal Attachment in Primiparous Pregnant Women
- ClinicalTrials.gov ID
- NCT05250479
- Acronym / sponsor ID
- ozlem20
- Conditions
- Pregnancy Related, Mindfulness, Fear of Childbirth, Attitude
- Keywords
- primiparous, pregnant women, fear of childbirth, prenatal attachment, mindfulness education, childbirth experiences, mode of birth, maternal attachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While adaptation is generally achieved to the psychological changes that develop during pregnancy, some women may experience psychological changes such as contradiction, uncertainty, introversion, passive personality, addiction, fear, and anxiety in different periods of pregnancy. During this period, the fear of childbirth may also be experienced in pregnant women. Fear of childbirth or tokophobia is a phobic condition in which a woman avoids giving birth despite desperately wanting a baby. While fear of childbirth can have a negative impact on women's psychological health during pregnancy and birth experience, it is associated with negative obstetric outcomes and postpartum mental health problems. It is possible that the fear of childbirth reduces the mother's attachment to the fetus. Fear increases avoidant attachment and anxiety, which may be associated with lower commitment scores. There is a strong relationship between fear of childbirth and negative birth outcomes. Both affect the psychological well-being of the mother, adjustment to motherhood, and the quality of the mother's relationship with the baby. Knowing the fear of childbirth is important as it is associated with various health problems such as certain physiological and obstetric disorders and they can increase the possibility of emergency cesarean section. Mindfulness-based interventions combine elements of established cognitive behavioral therapy and psychoeducational content to support a self-effective approach to reduce stress-related symptoms and improve mental and physical well-being. Mindfulness-based practices that involve focusing on the present moment and accepting life without judgment are one of the effective ways to prepare for childbirth, help women feel more empowered and aware of their motherhood processes, and give mothers the opportunity to share knowledge and emotions. Mindfulness-based birth education intervention appears to be applicable for women and is associated with improvements in women's sense of control and confidence in giving birth.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –44 pregnant women won't receive mindfulness training |
| experimental group "mindfulness education" | Experimental | Behavioral: Mindfulness educationmindfulness education 44 pregnant women will receive mindfulness training |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- over 18 years
- 28-32. in gestational week
- First pregnancy
- Understands and speaks Turkish
- Single pregnancy
Key exclusion criteria (3 listed)
- Having a high-risk pregnancy
- Receiving psychotherapy or medication in the last six months before the study
- with chronic disease Participating in childbirth preparation courses Planning a cesarean delivery with a diagnosed psychiatric illness Pregnant women with previous yoga and meditation experience Pregnant women with a high gestational age will be excluded from the study due to the possibility of giving birth before the end of the follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness education44 primiparous pregnant women will receive mindfulness education | Behavioural | experimental group "mindfulness education" |
Primary outcome
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)
Time frame: 28-32. pregnant women
determining the level fear of childbirth
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)
Time frame: After 32 weeks of pregnancy
determining the level fear of childbirth
Prenatal Attachment Inventory
Time frame: 28-32. pregnant women
determine prenatal mother-infant attachment
Prenatal Attachment Inventory
Time frame: After 32 weeks of pregnancy
determine prenatal mother-infant attachment
2 secondary outcomes
Maternal Fetal Attachment Scale
Time frame: postpartum 1st month
Wijma Delivery Expectancy/Experience Questionnaire B (W-DEQ B)
Time frame: postpartum 1st month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nülüfer Erbil, PhD study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness education in people with Pregnancy Related and Mindfulness, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ÖZLEM AKIN, PhD student (05416223058, akinozleem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A) (time frame: 28-32. pregnant women). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.